Medication info

Montelukast Sodium Granules 4mg

Prescription medication경구
Ingredient · strength
Montelukast Sodium›4.16mg / 1 packet
Manufacturer / importer
(주)보령바이오파마
Appearance
Homogeneous white granules without any foreign substances
Packaging
28 packets/box (4mg/packet x 28)
Approval status
Active

MFDS item code 201901900 · Approved 2019.03.28 · Insurance code 670501511

Summary

Main use
Prevention of asthma and relief of allergic rhinitis symptoms
Who takes it
Adults · Children
Adult dose
Adults and adolescents aged 15 and older should take 10 mg of montelukast orally once daily. This medication should be administered 1 hour before a meal or 2 hours after a meal. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 film in the evening once daily.
Child dose
Children aged 6 to 14 should take 5 mg of montelukast once daily, to be chewed or placed on the tongue to dissolve or melt, taken without water. This medication should be administered 1 hour before a meal or 2 hours after a meal. 2-

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Prevention of asthma and relief of allergic rhinitis symptoms

  • Asthma
  • symptoms of allergic rhinitis
View approved original text

This medicine is used to prevent and continuously treat asthma. It is also effective in relieving symptoms of seasonal and year-round allergic rhinitis. This efficacy helps improve respiratory health.

How to take

Adult dose

Adults and adolescents aged 15 and older should take 10 mg of montelukast orally once daily. This medication should be administered 1 hour before a meal or 2 hours after a meal. Patients with both asthma and allergic rhinitis should take 1 tablet, 1 packet, or 1 film in the evening once daily.

Child dose

Children aged 6 to 14 should take 5 mg of montelukast once daily, to be chewed or placed on the tongue to dissolve or melt, taken without water. This medication should be administered 1 hour before a meal or 2 hours after a meal. 2-

Precautions

This medication is used to prevent and control symptoms of asthma and allergic rhinitis. During treatment with this medication, neuropsychiatric side effects may occur, so patients or caregivers should immediately inform their doctor if any behavioral changes such as restlessness, anxiety, depression, hallucinations, or suicidal thoughts arise. Individuals with known allergies to this medication should never take it. Fatigue, headache, dyspepsia, fever, cough, rash, and other side effects may occur after taking the medication, so caution is advised. Children and the elderly can also use this medication, but side effects may differ by age, so it should be taken according to the doctor’s instructions. This medication is not a treatment for acute asthma attacks; therefore, immediate use of a rescue inhaler is necessary if sudden breathing difficulties occur. Patients with hypersensitivity to aspirin or non-steroidal anti-inflammatory drugs should avoid taking these medications while using this drug. During treatment, do not abruptly stop or reduce the dosage of any other asthma medications without consulting a doctor. Pregnant or breastfeeding women should only take this medication when absolutely necessary and must consult a doctor before use. No significant interactions with other medications have been reported, but monitoring by a doctor is required when used with drugs that induce certain liver metabolic enzymes. In case of overdose, there is no specific antidote, so general treatment and observation are required; if symptoms are severe, immediate hospital visit is necessary. Since the medication is sensitive to light, it should be taken immediately after opening, and stored out of reach of children. This medication should be taken consistently even when there are no symptoms of asthma, and consultation with a doctor is necessary if symptoms worsen.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • severe allergic reactions
  • toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • severe skin reactions
  • breathing difficulties
  • respiratory problems
  • jaundice (yellowing of the skin or eyes)
  • liver dysfunction (jaundice)
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  • sudden and severe headache
  • seizures
  • confusion
  • vision disturbances
  • paralysis
  • serious neurological symptoms
  • significantly reduced urine output
  • increased blood pressure
  • severe swelling or urination issues
  • suicidal thoughts

Mild side effects

Restlessness, aggressive behavior, anxiety, depression, disorientation, attention deficit, stuttering, sleep disturbances, hallucinations, insomnia, memory impairment, obsessive-compulsive behavior, psychomotor hyperactivity (including irritability, instability, tremors), sleepwalking, tics, dizziness, drowsiness, sensory disturbances/decreased perception, palpitations, nosebleeds, diarrhea, dyspepsia, nausea, vomiting, joint pain, muscle cramps, myalgia, enuresis, weakness, fatigue, fever, edema, alopecia, pruritus, headache

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air, moisture, and light, so it should be stored in a tightly closed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

Homogeneous white granules without any foreign substances

Package unit

28 packets/box (4mg/packet x 28)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.